Actively Recruiting
Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Led by GABRIEL MONTEIRO PINHEIRO · Updated on 2025-11-28
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg/day for 10 days) versus standard letrozole therapy (5 mg/day for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).
CONDITIONS
Official Title
Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- Body mass index (BMI) between 18.5 and 31 kg/m2
- Diagnosis of polycystic ovary syndrome (PCOS) by Rotterdam criteria (2003), requiring at least two of the following: oligo/anovulation, clinical or biochemical signs of high androgens, or polycystic ovaries on ultrasound
- Active wish to become pregnant at enrollment
- Able and willing to give written informed consent
You will not qualify if you...
- Younger than 18 or older than 40 years
- Confirmed bilateral tubal blockage, severe male infertility, premature ovarian failure, uncontrolled high prolactin levels, or thyroid problems
- Congenital or acquired uterine abnormalities
- History of gynecologic or breast cancer
- Known allergy or contraindication to letrozole
- Severe uncontrolled systemic illness such as heart, kidney, or liver disease
- Pregnant or breastfeeding at screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Health Complex Dr Wladimir Arruda
São Paulo, São Paulo, Brazil, 04829-310
Actively Recruiting
Research Team
K
Katherine Ann R Miller, Medical student
CONTACT
G
Gabriel M Pinheiro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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